Immunopathol Persa. 2021;7(2):e31 Review

Immunopathologia Persa http www.immunopathol.com DOI:10.34172/ipp.2021.31 Efficacy and side effects of Sputnik V, Sinopharm and AstraZeneca to stop COVID-19; a review and discussion

Nasrin Ghiasi1 ID , Rohollah Valizadeh2 ID , Mohammad Arabsorkhi3 ID , Tahere Sadat Hoseyni4, Korosh Esfandiari4, Tella Sadighpour5* ID , Hamid Reza Jahantigh6,7

1Department of Midwifery, Faculty of Medicine, Ilam University of Medical Sciences, Ilam, Iran 2Student Research Committee, Department of , School of Public Health, Iran University of Medical Sciences, Tehran, Iran 3Medical Education Department, Medical Education Research Center, Isfahan University of Medical Sciences, Isfahan, Iran 4Ali-Asghar Children Hospital, Department of Radiology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran 5Herbert Wertheim College of Medicine, Florida international university, Florida, USA and American University of Antigua College of Medicine, Antigua and Barbuda 6Interdisciplinary Department of Medicine - Section of Occupational Medicine, University of Bari, Bari, Italy 7Animal Health and Zoonosis PhD Course, Department of Veterinary Medicine, University of Bari, Bari, Italy

*Correspondence to Abstract Tella Sadighpour, Email: [email protected], We believe that is just a way to eliminate or strongly stop the COVID-19. In this regard, there are [email protected], several vaccines with different efficacy and side effects. It is urgently required to have some efficient vaccines for [email protected] the prevention and control of SARS-CoV-2. In this review, international databases were considered for searching relevant articles from 1 January 2020 to 1 May 2021. Keywords were COVID-19, novel coronavirus, 2019- Received 16 April 2021 nCoV, coronavirus disease 2019, , Sputnik V, Gamaleya, Gam-COVID-Vac, Sinopharm, BBIBP-CorV, Accepted 23 May 2021 AstraZeneca, Vaxzevria, Oxford, ChAdOx1 nCoV-19 and AZD1222. Three Sputnik V, Sinopharm and AstraZeneca Published online 5 June 2021 vaccines are useful to gain herd immunity. Enough intervals (at least three weeks/21 days) must be considered for Keywords: COVID-19, Novel sufficient neutralizing antibody titers. What is important is that the vaccination should be accelerated with each of coronavirus, 2019-nCoV, the aforementioned three vaccines to achieve herd immunity in a shorter period of time because all three vaccines Vaccine, Sputnik V, Gamaleya, provide 100% prevention of severe COVID-19. Gam-COVID-Vac, Sinopharm, BBIBP-CorV, AstraZeneca, AZD1222

Citation: Ghiasi Introduction Key point N, Valizadeh R, Coronavirus disease 2019 (COVID-19) is Three Sputnik V, Sinopharm and AstraZeneca Arabsorkhi M, Hoseyni caused by severe acute respiratory syndrome TS, Esfandiari K, vaccines are helpful to gain herd immunity. Enough Sadighpour T, Jahantigh coronavirus 2 (SARS‑CoV‑2), and is the intervals (at least 3 weeks/ 21 days) must be HR. Efficacy and side causative agent of a potentially deadly disease considered for sufficient neutralizing antibody titers. effects of Sputnik worldwide that has become a major public All three vaccines provide 100% prevention of severe COVID-19. V, Sinopharm and health concern. Coronavirus is one of the AstraZeneca vaccines to stop COVID-19; a largest pathogens targeting the lung. Previous review and discussion. outbreaks of coronavirus have included severe Immunopathol Persa. acute respiratory syndrome (SARS) and the 165 069 258 confirmed cases of COVID-19, 2021;7(2):e31. including 3 422 907 deaths, reported to DOI:10.34172/ Middle East respiratory syndrome (MERS) ipp.2021.31. which have previously been identified as very World Health Organization (WHO) and a threatening to public health. In late December total of 1 422 282 170 vaccine doses have been 2019, a number of patients were admitted administered to people (3,4). to hospitals with an initial diagnosis of Vaccine is the final key to eliminate the pneumonia of unknown cause. These patients COIVD-19 pandemic. Vaccine is a living were epidemiologically related to a wholesale organism and has the power to resist and seafood and wet animals market in Wuhan, overcome germs, which is called immunity Hubei province, China (1,2). Globally, at (5). In many diseases caused by the virus, the time of publication, there have been once a person gets the disease and gets better,

Copyright © 2021 The Author(s); Published by Nickan Research Institute. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Ghiasi N et al he or she will be immune to it. For example, smallpox, Methods measles, and chickenpox are diseases that, once infected, In this review, international databases including PubMed, can be permanently immune and they will never be Web of Science and Scopus were considered for searching infected again. However, other diseases, such as the flu, of English articles from 1 January 2020 to 1 May 2021. All can affect humans several times. Therefore, in order to get types of articles were included. Keywords were COVID-19, rid of them, immunity must be created artificially in the novel coronavirus, 2019-nCoV, coronavirus disease human body called “active ” (6). 2019, vaccine, Sputnik V, Gamaleya, Gam-COVID-Vac, By injecting the weakened virus into the body, it causes Sinopharm, BBIBP-CorV, AstraZeneca, Vaxzevria, Oxford, a mild form of the disease. Active immunization or ChAdOx1 nCoV-19 and AZD1222. After collection of vaccination is a very important and valuable measure by articles of interest, references were imported to Endnote which infectious diseases can be prevented at a low cost. software and removed duplicate titles. The selected studies With the implementation of the universal vaccination were performed on humans and published in English. program in the world, the prevalence of many dangerous Totally, according to the UNICEF website, there are 13 diseases among infants, children and adults has been vaccines with approval from emergency use listing (EUL), significantly reduced, so that now the prevalence of serious with licensure from countries or with conditionals use diseases such as diphtheria, tetanus, pertussis, measles and (Table 1) (14). In Iran, there are three vaccines including polio with successful vaccination in children (7). Vaccines Shifa Pharmed Industrial Co with four trials, Razi Vaccine have now been developed for more than 20 diseases, and Serum Research Institute () with two some of which are commonly used and others for specific trials and FAKHRAVAC (MIVAC) with one trial (15). conditions. The decision to and use a vaccine for a disease is made based on the balance of two issues, one AstraZeneca/ Oxford/ChAdOx1 nCoV-19/AZD1222/ is the need for the vaccine and the other is the risks and ChAdOx1 complications (8). The WHO has given EUL to the AstraZeneca COVID-19 The preventive effect of a vaccine is obtained by vaccine to prevent COVID-19 in people 18 years of age comparing the number of infected people in the two and older, including people over 65. The COVID-19 groups of vaccinated and unvaccinated people who are AstraZeneca vaccine is licensed by WHO produced by accidentally exposed to the disease. The most effective AstraZeneca and COVISHIELD by the Indian Serum vaccines are those that mimic the preventive mechanism Institute (SII) for universal access during the COVID-19 resulting from the recovery phase in the normal form epidemic. The EUL allows two doses of the vaccine to of the disease (9). Herd immunity is established when a be given with four to 12 weeks interval (16). According sufficient number of people are immune to stop new cases. to a study published as an interim study for AstraZeneca This means that enough people are protected to stop the vaccine, this vaccine should not be injected under the age person-to-person transmission in the community (10). of 18 and two doses of 0.5 ml should be injected every 4 to Herd immunity may exist worldwide like smallpox. For 12 weeks (17). According to a WHO statement on February example, the United States and many other countries have 11 “While the vaccine has not yet been recommended achieved herd immunity to polio and measles, although for emergency use by the WHO, it has been reviewed by universal immunity to these two diseases does not yet exist the European Medicines Agency (EMA)”. The EMA has (11). thoroughly evaluated vaccine quality, safety and efficacy The percentage of people who need to achieve herd data and recommended that conditional marketing immunity varies with specific disease e.g., measles authorization be granted to those 18 years of age and older needs about 95% of vaccination among the community. (18). Nevertheless, this threshold for polio is approximately According to the Drugs Controller General of India 80%. To achieve herd immunity for COIVID-19, exact (DCGI), common side effects of Indian AstraZeneca percentage is not known (12). There are several effective include tenderness, pain, warmth, redness, itching, and approved vaccines for COVID-19. Doroftei et al inflammation, and blisters at the injection site. It also concluded that three vaccines had an efficacy of more leads to general feeling of discomfort, lethargy, fatigue, than 90% (Pfizer–BioNTech, ~95%; Moderna, ~94%; and chills and fever, headache, nausea, arm pain, joint and Sputnik V, ~92%) except for Oxford–AstraZeneca (~81%) muscle pain that subside within a few days to a week after (13). Vaccines may have specific complications that should vaccination (19). The secretary of the Ministry of Health be studied. In this study, we reviewed three vaccines of India stated that the common side effects following the including AstraZeneca, Sputnik V and Sinopharm in AstraZeneca vaccine will be eliminated within 24 hours detail. (20). In Europe, the most common complication was fever and then headache, which is normal due to the activation Objective of the immune system following vaccination, and fever is This study aimed to review the efficacy and side effects of also reported following Pfizer and Moderna. No serious Sputnik V, Sinopharm and AstraZeneca vaccines. side effects have been reported for the AstraZeneca

2 Immunopathologia Persa Volume 7, Issue 2, 2021 Sputnik V, Sinopharm and AstraZeneca vaccines

Table 1. Number of vaccines approval reported by UNICEF (14)

Vaccine developer WHO EUL Licensure Emergency/conditional use Anhui Zhifei Longcom Biopharmaceutical - 1 1 AstraZeneca 2 4 65 Beijing Institute of Biological Products (CNBG) 1 2 16 Bharat Biotech - - 6 CanSino Biologicals - - 5 Chumalov - 1 - Gamaleya Research Institute - 8 54 Janssen 1 1 37 Moderna 1 1 33 Pfizer/BioNTech 1 6 58 Sinovac - - 23 Vector State Research Center - 1 - Wuhan Institute of Biological Products - 1 1 vaccine. Additionally, 10 to 15 of those vaccinated Gam-COVID-Vac/Gamaleya/Sputnik V experience nausea up to 12 hours after vaccination. Of the This recombinant vaccine was developed for COVID-19 10 000 vaccinated, 149 reported flu-like symptoms. Fever by Gamaleya Research Institute, Russia using human has been reported in 25% of cases (21). adenovirus vector 26 for the first vaccine and human In addition to common complications, uncommon adenovirus 5 for the second vaccine. At the same time, the symptoms include excessive sweating, enlarged lymph effectiveness of the Sputnik V vaccine against COVID-19 nodes, pain, loss of appetite, and confusion (22). has been announced to be 91.6%. However, it may be less According to AstraZeneca Company, prophylactic use effective in the elderly or patients with immunodeficiency. of Acetaminophen can reduce some symptoms (23). The best immune response also occurs about two weeks According to the European Medicines Agency (EMA), after the second dose of the vaccine, but the duration of general symptoms of the few symptoms reported are protection of this vaccine, like other vaccines, is not yet vaccine are mild to moderate and include pain and known. On the other hand, clinical studies of this vaccine, stiffness at the injection site, headache, fatigue, muscle like other Corona vaccines in the world, are still ongoing aches, lethargy, chills, fever, joint pain, and nausea (24). to answer these ambiguities. It should be noted that the As of 19 April 2021, WHO revealed that the AstraZeneca Russian Sputnik vaccine is banned in some cases. For vaccine is an effective and safe vaccine without serious example, this vaccine should not be used during pregnancy complications including death, hospitalization and and lactation. Furthermore, those with a history of severe severe disease (25). As reported, “COVID-19 vaccine allergic reactions and any acute illness with or without AstraZeneca” uses non-replicant chimpanzee adenovirus fever can come for this vaccine about two weeks after ChAdOx1 causing thrombocytopenia (26). Ramasamy et recovery. On the other hand, the vaccine is not licensed for al showed that AstraZeneca/ChAdOx1 nCoV-19 vaccine people less than 18 years of age. In addition, people who is better tolerated in older adults than in younger adults suffer from any severe side effects after the first dose of this and has similar immunogenicity across all age groups vaccine, such as anaphylaxis or severe allergic reaction, after a boost dose (27). Wolf et al reported intracranial seizures and fever above 40 degrees, are prohibited from venous sinus thrombosis (IVST) in vaccinated people by taking the second dose of the vaccine (29). COVID-19 Vaccine AstraZeneca (28). They indicated that Logunov et al reported that the side effects of the first or exposure to AstraZeneca vaccine triggers the expression second dose of the vaccine are generally mild to moderate of antiplatelet antibodies, resulting in a condition with and go away in about three days. The most common thrombocytopenia and venous thrombotic events. complication is a mild flu-like condition with symptoms Following the use of AstraZeneca vaccine, a 22-year patient such as fever, chills, muscle and joint pain, sore throat, developed headaches four days after the vaccination nasal congestion, weakness, malaise, and headache. Local and after a week, the patient experienced a generalized side effects such as pain, swelling, and redness at the epileptic seizure. Another 46-year patient presented with injection site may also occur. These symptoms usually severe headaches, hemianopia to the right, and mild resolve on their own, but non-steroidal anti-inflammatory aphasia about two weeks after the vaccination that was a drugs can be used to control fever or antihistamines for left occipital intracerebral hemorrhage approved by MRI. topical side effects. However, less common complications In addition, right-hand hemiparesis and extensive venous include nausea, anorexia, and enlarged regional lymph sinus thrombosis were diagnosed that were managed by nodes, and rarely, confusion and syncope have been heparinization and endovascular recanalization of their reported. At the same time, temporary increase in liver venous sinuses (28). enzymes, increase in serum creatinine and CPK, decrease

Immunopathologia Persa Volume 7, Issue 2, 2021 3 Ghiasi N et al

Table 2. Comparing efficacy and other characteristics of Sputnik V, Sinopharm and AstraZeneca vaccines

Variable Type Efficacy Dose Storage Interval of vaccine 91.6% efficacy against the original strain of the virus Sputnik V Adenovirus-based 2 -18.5°C 21 days apart 100% against severe COVID-19

79% against symptomatic SARS-CoV-2 14 or more days after Inactivated SARS- Sinopharm the second dose. 2 2-8°C 21 -28 days apart Cov-2 (Vero cell) 100% against severe COVID-19 76% against symptomatic COVID-19

AstraZeneca Adenovirus-based 100% against severe or critical disease and hospitalizations 2 2-8°C 28 days apart

85% against symptomatic COVID-19 in people 65 years and older in neutrophils, increase in lymphocytes, increase and injection site pain and fever, which were mild and self- decrease in platelets, etc have also been reported. The age limiting without any serious adverse reactions. Totally, the in the study of Logunov et al was varied from 18 to 87 frequency of the patients with adverse reactions was low years (29). (33). Xia et al in another study on BBIBP-CorV vaccine According to the report of Centers for Disease Control showed that the most common systematic adverse reaction and Prevention (CDC), and published interim analysis is fever (18-59 years, 4% in the 2 and 4μg group and 8% in of Gam-COVID-Vac Vaccine in phase 3 in the Lancet the 8 μg group). All reported adverse reactions were mild journal, the most common side effects were flu-like illness, or moderate without serious adverse event within 28 days headache, fatigue and injection-site reactions which are following vaccination. Two-dose immunization with three similar to other vaccines such as Moderna, Johnson and or four weeks interval gain higher neutralizing antibody Pfizer. Since serious adverse events (deep vein thrombosis, titers than the single 8 μg dose or 4 μg dose on days 0 and hemorrhagic stroke, and hypertension) were reported as 14. It shows that enough intervals must be considered for well, the independent data monitoring committee revealed sufficient neutralizing antibody titers (34). that none of these was related to the Sputnik V vaccine Table 2 shows a summary of efficacy and other (30). Logunov et al, in a large cohort study conducted characteristics of Sputnik V, Sinopharm and AstraZeneca on 25 hospitals of Moscow, Russia showed that of 21 977 vaccines. adults (vaccine group=16 501 and placebo group=5476), from 21 days after the first dose of vaccine (the day of Conclusion dose 2), 16 of 14 964 participants in the vaccine group and Three vaccines of Sputnik V, Sinopharm, and AstraZeneca 62 of 4902 in the placebo group were confirmed to have are useful to gain herd immunity. Enough intervals (at COVID-19, therefore vaccine efficacy was reported to be least 3 weeks/ 21 days) must be considered for sufficient 91·6% for prevention of COVID-19 (29). neutralizing antibody titers (34). What is important is that the vaccination should be accelerated with each of the Sinopharm/BBIBP-CorV aforementioned three vaccines to achieve herd immunity The first Chinese COVID-19 vaccine that WHO authorized in a shorter period of time because all three vaccines for emergency use is Sinopharm COVID-19 vaccine or provide 100% prevention of severe COVID-19. BBIBP-CorV as produced by Beijing Bio-Institute of Biological Products (BBIBP). In the trials, Authors’ contribution NG, RV and TS; Concept, design, search and screening. MA, TSH, Sinopharm was safe and well tolerated in such a way that KS, TS and NG: manuscript draft. TS, NG, RV: revision. Final edit: a robust humoral immune response was reported in 100% MRJ. All authors read and signed the final paper. of vaccinated individuals. Additionally, animal studies about Sinopharm performed on rats, mice, rabbits and Conflicts of interest guinea pigs showed acceptable protection against SARS- The authors declare that there is no conflict of interest. CoV-2 (31). According to the reported on Sinopharm/ Ethical considerations BBIBP COVID-19 vaccine released by the WHO, most Ethical issues (including plagiarism, data fabrication, double common side effect of Sinopharm vaccine (with 79% publication) have been completely observed by the authors. efficacy against symptomatic COVID-19 and 79% efficacy Funding/Support against hospitalization) were dizziness, fatigue, headache, The authors received no financial support for the research, nausea, vomiting, fever and allergic dermatitis (32). One authorship, and/or publication of this article. of the acceptable features of this vaccine is that the normal refrigeration temperature is enough to be stored. References 1. Kofi Ayittey F, Dzuvor C, Kormla Ayittey M, Bennita Chiwero N, Xia et al showed the results of phase I and II interim and Habib A. Updates on Wuhan 2019 novel coronavirus epidemic. J indicated that the most common adverse reaction was Med Virol. 2020;92:403-407. doi: 10.1002/jmv.25695.

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